Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure

Completed

Conditions studied: Bowel Diseases

In brief

The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.

Key facts

Study ID

NCT00885235

Run by

Medtronic - MITG

People needed

40

Starts

2008-10-01

Expected to finish

2009-08-01

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
• Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
• Subject ≥ 18 years of age with one of the following:
• Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
• Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy

You may not qualify if…

• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• Subject has a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
• Subject with gastrointestinal motility disorders
• Subject has known delayed gastric emptying
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study

Where it is running

• University of Indiana Hospital — Indianapolis, Indiana, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Digestive Care Inc. — Beavercreek, Ohio, United States
• Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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